The Recall Desk
SevereFDA (Devices)·Z-0953-2015·Announced 2015-01-21

DePuy ATTUNE INTUITION Impaction Handle Recalled for Fracture Risk

DePuy Orthopaedics is recalling ATTUNE INTUITION Impaction Handles because the lever can fracture during knee surgery, potentially leaving device pieces in the patient.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect that could result in foreign objects being left in a patient, meeting the criteria for a Severe rating.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling 7,944 units of the ATTUNE INTUITION Impaction Handle. This re-usable instrument is used in knee replacement procedures to impact, extract, and insert other surgical components. The recall is due to complaints indicating that the handle's lever has fractured during impaction.

If the lever fractures, there is a potential for fractured pieces of the device or the inner spring to be left in the patient if not observed during the surgery. The affected products were distributed worldwide, including the United States (nationwide except Alaska and Rhode Island, including Puerto Rico) and numerous international locations such as Canada, Australia, and the United Kingdom.

Healthcare providers should stop using the affected impaction handles and contact DePuy Orthopaedics for instructions on how to return the devices. The recall number is Z-0953-2015.

The recalled product

Product
The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial impact
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
7,944

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • CATALOG NO. : 2544-01-017 LOT NUMBER: All Lots Barcode GTIN: 10603295423324

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Related recalls

Same manufacturer · DePuy Orthopaedics, Inc.

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